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CTRI Number  CTRI/2021/03/032041 [Registered on: 16/03/2021] Trial Registered Prospectively
Last Modified On: 10/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Block of nerve group around Hip capsule versus Block in Iliac Fascia above Inguinal liagament in patients undergoing Total Hip Replacement 
Scientific Title of Study   Comparing the efficacy of Pericapsular nerve group block (PENG) block versus Supra-inguinal fascia iliaca block (FIB) in Total Hip Arthroplasty : A prospective randomized control trial. 
Trial Acronym  PENG vs FIB 
Secondary IDs if Any  
Secondary ID  Identifier 
572657332016  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chethan V 
Designation  JR IN MD ANAESTHESIOLOGY 
Affiliation  ALL INDIAN INSTITUTE OF MEDICAL SCIENCES PATNA. 
Address  ROOM NO 308 AIIMS PATNA PG BOYS HOSTEL 10 AIIMS CAMPUS PULWARISHARIF PATNA.
DEPARTMENT OF ANAESTHESIOLOGY AIIMS PATNA
Patna
BIHAR
801507
India 
Phone  9972491570  
Fax    
Email  chethanvamshi20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chethan V 
Designation  JR IN MD ANAESTHESIOLOGY 
Affiliation  ALL INDIAN INSTITUTE OF MEDICAL SCIENCES PATNA. 
Address  ROOM NO 308 AIIMS PATNA PG BOYS HOSTEL 10 AIIMS CAMPUS PULWARISHARIF PATNA.
DEPARTMENT OF ANAESTHESIOLOGY AIIMS PATNA
Patna
BIHAR
801507
India 
Phone  9972491570  
Fax    
Email  chethanvamshi20@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chethan V 
Designation  JR IN MD ANAESTHESIOLOGY 
Affiliation  ALL INDIAN INSTITUTE OF MEDICAL SCIENCES PATNA. 
Address  ROOM NO 308 AIIMS PATNA PG BOYS HOSTEL 10 AIIMS CAMPUS PULWARISHARIF PATNA.
DEPARTMENT OF ANAESTHESIOLOGY AIIMS PATNA
Patna
BIHAR
801507
India 
Phone  9972491570  
Fax    
Email  chethanvamshi20@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Patna 
 
Primary Sponsor  
Name  Not funded 
Address  N/A 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ajeet Kumar  AIIMS Patna  Operation Theatre, Department of Anaesthesiology AIIMS Patna
Patna
BIHAR 
9312501413

ajeetanaes@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PENG(Pericapsular nerve group )  under all aseptic precautions A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution 30ml of bupivacaine 0.25% +1mcg/kg clonidine will be injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL. Group S patients will receive the USG guided Suprainguinal FIB. After all aseptic preparation a high frequency linear USG probe will be place transversely below the femoral crease and femoral artery will be delineated. Then, the probe will be moved laterally and a echo-lucent dark illio-psoas muscle will be seen lateral to the femoral artery which is covered by a hyper echoic white line like structure called fascia iliaca. Then, the probe will be rotated in para-sagittal plane at the same place and the iliacus muscle and its covering fascia iliaca are identified in the pelvis below the abdominal muscles. After this the needle is introduced from the 1-2 cm below the inguinal ligament in –plane to the probe directed towards the pelvis and 30ml solution containing 0.25% bupivacaine+ 1mcg/kg clonidine will be injected below the fascia liaca after a negative aspiration test. 
Comparator Agent  SIB(suprainguinal fascia iliaca block)  Group S patients will receive the USG guided Suprainguinal FIB. After all aseptic preparation a high frequency linear USG probe will be place transversely below the femoral crease and femoral artery will be delineated. Then, the probe will be moved laterally and a echo-lucent dark illio-psoas muscle will be seen lateral to the femoral artery which is covered by a hyper echoic white line like structure called fascia iliaca. Then, the probe will be rotated in para-sagittal plane at the same place and the iliacus muscle and its covering fascia iliaca are identified in the pelvis below the abdominal muscles. After this the needle is introduced from the 1-2 cm below the inguinal ligament in –plane to the probe directed towards the pelvis and 30ml solution containing 0.25% bupivacaine+ 1mcg/kg clonidine will be injected below the fascia liaca after a negative aspiration test. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for elective Total Hip arthroplasty.
2. ASA I and II including both the sexes.
3. Age group: 25 to 75 years. 
 
ExclusionCriteria 
Details  1. ASA III / IV
​ 2. Patient refusal to take part in the study
3. Morbid obesity (BMI ≥ 40)

4.History of focal neurological deficit

5.History of sensory or motor disorders of limb to be operated

6. History of allergy to local anaesthetics, clonidine

7. History of regular opioid use

8. Infection at puncture site for both approaches of block

. ​ 9. Inability to comprehend NRS pain assessment scale

10. Inability to understand the use of PCA device 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
24-hour morphine consumption.  24-hour morphine consumption. 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative opioid consumption
•Mean Numerical rating scale[NRS]in 24 hours
•Worst NRS in 24 hours
•Weakness of Quadriceps femoris muscle
•Quality of Recovery.
•Time to first activation of PCA pump.
•Complications of block.
•Assessment of Quadriceps femoris muscle strength: For motor block assessment, the patient will be in supine position and the patients knee will be fully flexed, and the patient will be asked to extend it. 
48 hrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The current modalities for pain control often rely on multimodal analgesia. Opioids remain an integral part of most analgesic plans either via intravenous boluses, infusion or patient controlled analgesia (PCA) pumps. Using opioids alone intensifies their side-effect profile that includes, postoperative nausea and vomiting (PONV), sedation, pruritus and respiratory depression.The common opioid sparing methods are use of non-steroidal anti inflammatory drugs (NSAIDs), spinal opioids, epidural postoperative analgesia and peripheral nerve blockade3.Peripheral nerve blockade has started gaining attention in the recent past for arthroplasty. Although its place is well recognized in knee arthroplasty its place in hip arthroplasty is not well defined. The modified supra inguinal approach of FIB described by Stevens places the local anaesthetic (LA) solution in the fascia iliaca plane higher up than the conventional technique and thus allow more superior spread of  (LAs) and hence blockade of nerves derived from L1 and L2 anterior rami of lumbar plexus (ilioinguinaliliohypogastric and genitofemoral) leading to more effective pain relif5We The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. A recent anatomical study by Short et al15 confirmed the innervation of the anterior hip by these 3 main nerves but also found that the AON and FN play a greater role in the anterior hip innervation than previously reported. The hypothesis of this study is that a PENG block will provide a better postoperative analgesia and reduce opioid consumption in the postoperative period in patients undergoing THR.

 
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